MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC; PORT ACCESS NEEDLE

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported the oncology department had a case where a nurse discovered leakage from the port needle during flushing on the morning of the third day of use.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Additional information received 01/08: upon detecting leakage, the affected iv solution was immediately discontinued.New, uncompromised solution was administered to continue the infusion.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a leak was confirmed; however, the exact cause is unknown.The product returned for evaluation was one powerloc extension tubing assembly.A gross visual inspection of the returned unit found that a longitudinally aligned split was present on the luer hub.The split extended from the proximal end of the luer threads to the proximal end of the luer fins.The damage to the luer fin suggested that the luer may have been over torqued.The device was microscopically inspected and the split was found to have occurred next to, but not along, a molding weld line.No other remarkable features were observed.Based on the available material for review, the investigation was unable to identify sufficient features to conclusively determine a root cause.Therefore, the root cause remains unknown.Potential root causes include over torque of the luer and inadequate storage conditions.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC
• Common Device Name: PORT ACCESS NEEDLE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city UT 84116
• Manufacturer Contact: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23999511
• Report Number: 3006260740-2025-10316
• Device Sequence Number: 16078061
• Product Code: FPA
• UDI-Device Identifier: 00801741048425
• UDI-Public: (01)00801741048425(11)250520(17)280820(10)ASKPFS012
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8672034
• Device Lot Number: ASKPFS012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 02/12/2026; 02/27/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/15/2026; 02/19/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown